The results of ISTA’s Heat and Cold Profile Study of the 2nd Day parcel shipping environment within the United States, Thermal Laboratory Certification, and the development of a new Manual for qualifying cold chain packaging will be presented. The first part of this presentation will include a review of two studies, one in the summer and one in the winter, that were conducted to collect a large set of experimental data on the environmental conditions encountered during two-day shipments of pharmaceutical products throughout the United States. This data was then used to statistically build two general temperature profiles. A second portion of the presentation will outline the process by which thermal transport testing laboratories can become certified by ISTA. It will take you through the application process, how to prepare for audit/assessment for certification; ISTA's process and requirements; training; and reporting. The final segment of the presentation illustrates a new manual that ISTA developed to make the process easier for its cold chain member companies to follow as they qualify their cold chain packaging.